The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
Age 18 to 80 years, any gender;
Subject is suitable for endovascular treatment of cerebrovascular malformations;
Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Intracranial hemorrhage within 1 month prior to treatment;
The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
Parallel
Liquid Embolic System (Tonbridge)
DeviceEndovascular treatment with Liquid Embolic System (Tonbridge).
Onyx Liquid Embolic System (Medtronic)
DeviceEndovascular treatment with Onyx Liquid Embolic System (Medtronic).
Targeted Embolization Satisfaction Rate
Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA.
mRS score
mRS scores are assessed at each evaluation time point.
GOS score
GOS scores are assessed at each evaluation time point.
Operation satisfaction rate
The 5-point Likert scale is used to evaluate operation satisfaction from three aspects: visualization, diffusion, and microcatheter withdrawal. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.
Incidence of major adverse events (MAEs)
MAEs are defined as intracranial hemorrhage and ischemic complications. Intracranial hemorrhage included intraoperative hemorrhage (puncture of blood-supplying arteries by catheters or guidewires, rupture of nidus, and injury to blood vessels during withdrawal of catheters) and delayed symptomatic hemorrhage in the postoperative period; and ischemic complications included intraoperative ischemic complications (displacement of liquid embolic agents, thrombosis, and so on) and postoperative symptomatic ischemic stroke. "Incidence of major adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
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